The U.S. FDA has approved Novartis' Lu-177-based radionuclide therapy, Lutathera, for the treatment of pediatric patients 12 years and older with a rare type of cancer known as somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETs), making it the first therapy specifically reviewed and approved for use in children with GEP-NETs.
Diagnosis of NETs, a type of cancer that originates in neuroendocrine cells, is often delayed due to the inactive nature of the disease, resulting in approximately 10% to 20% of pediatric patients being diagnosed with metastatic disease.
“While GEP-NETs in children and adolescents are rare, the impact can be devastating. Today’s approval addresses a critical need for new treatment options for these vulnerable patients,” said Dr. Theodore Laetsch, trial investigator and director at the Children’s Hospital of Philadelphia.
Lutathera was first approved in 2018 for the treatment of neuroendocrine tumors affecting the pancreas or gastrointestinal tract, highlighting the broad potential of radioisotopes to target solid tumors. Novartis had picked up the therapy in its $3.9 billion acquisition of Advanced Accelerator Application in 2017.
Novartis says it will continue to investigate its portfolio of radioligand therapies beyond GEP-NETs and prostate cancer into breast, colon, lung and pancreatic cancers.
